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Abstract:

Some embodiments of the invention provide a biosensor system with a
multifunctional portable electronic device for use by an individual. The
biosensor system includes a breath delivery system with a breath sensor
capable of detecting an analyte in the individual's breath. The system
also includes a portable electronic device capable of receiving breath
analyte data from the breath sensor and blood glucose data or other types
of personal health data. The portable electronic device is capable of
storing, analyzing, and/or transmitting the breath analyte data and the
blood glucose data or the other types of personal health data.

Claims:

1. A biosensor system for use by an individual, the system comprising:a
breath delivery system including a breath sensor capable of detecting an
analyte in the individual's breath; anda portable electronic device
capable of receiving breath analyte data from the breath sensor,the
portable electronic device capable of receiving additional personal
health data,the portable electronic device capable of at least one of
storing, analyzing, and transmitting the breath analyte data and the
additional personal health data.

4. The system of claim 3 wherein the blood data includes at least one of
acetone, 3-hydroxybutyrate, acetoacetate, glucose, and insulin.

5. The system of claim 3 wherein the urine data includes at least one of
urine acetoacetate and urine ketone.

6. The system of claim 3 wherein the exercise data is provided by at least
one of a heart rate monitor, a pedometer, a speedometer, an
accelerometer, a calorimeter, and an oxygen consumption versus intensity
monitor.

7. The system of claim 3 wherein weight is measured by a scale and
impedance is measured by a body fat monitor.

8. The system of claim 1 wherein the breath delivery system is included in
a respirator mask.

9. A biosensor system for use by an individual, the system comprising:a
breath delivery system including a breath sensor capable of detecting an
analyte in the individual's breath; anda portable electronic device
capable of receiving breath analyte data from the breath sensor,the
portable electronic device capable of receiving blood glucose data,the
portable electronic device capable of at least one of storing, analyzing,
and transmitting the breath analyte data and the blood glucose data.

10. The system of claim 9 wherein the analyte in the individual's breath
is acetone and the breath sensor is an enzymatic electrochemical
biosensor.

11. The system of claim 9 wherein the portable electronic device analyzes
the breath analyte data to determine one of a metabolic state and a
disease state.

12. The system of claim 11 wherein the metabolic state is fat catabolism.

13. The system of claim 11 wherein the disease state is hyperthyroidism,
ketoacidosis, and diabetes.

14. The system of claim 9 wherein the portable electronic device includes
at least one of a laptop, a cellular phone, a personal digital assistant,
a pocket personal computer, and a portable music player.

15. The system of claim 9 wherein the portable electronic device includes
a blood glucose monitor that receives a blood glucose strip.

16. The system of claim 9 wherein the portable electronic device includes
a noninvasive blood glucose monitor.

17. The system of claim 9 wherein the portable electronic device includes
an opening to mechanically receive the breath delivery system.

18. The system of claim 17 wherein the opening includes an electrical
connector to connect the breath delivery system to the portable
electronic device.

19. The system of claim 9 wherein the breath delivery system is
mechanically and electrically embedded into the portable electronic
device.

20. The system of claim 19 wherein the breath delivery system includes a
breath opening built into the portable electronic device and wherein the
breath sensor is electrically embedded in the portable electronic device.

21. The system of claim 9 wherein the portable electronic device transmits
the breath analyte data and the blood glucose data to at least one of a
software system and a medical professional.

[0002]The current state of the art for breath sensing, measuring, and
analyzing of breath analytes is a gas chromatograph or other larger,
lab-scale devices. Other current state of the art is the incorporation of
blood glucose monitoring into a cellular phone, personal digital
assistant, or other portable electronic device where data signal
transmission occurs. In this current art, blood (a liquid biomaterial) is
required to initiate the sensor. In this current art, the device can
sense and measure only a single biomaterial.

SUMMARY

[0003]In light of the limitations discuss above, embodiments of the
invention expand the single functionality device to detect at least two
biomarkers with at least one being a breath biomarker. Some embodiments
of the invention provide a biosensor system for use by an individual. The
system includes a breath delivery system with a breath sensor capable of
detecting an analyte in the individual's breath. The system also includes
a portable electronic device capable of receiving breath analyte data
from the breath sensor and blood glucose data or other types of personal
health data. The portable electronic device is capable of storing,
analyzing, and/or transmitting the breath analyte data and the blood
glucose data or other types of personal health data.

[0004]Other aspects of the invention will become apparent by consideration
of the detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005]FIG. 1 is a schematic illustration of a biosensor system according
to one embodiment of the invention.

[0006]FIGS. 2A-2D are perspective views of a biosensor system according to
one embodiment of the invention.

[0007]FIG. 3 is a schematic illustration of a breath delivery system being
inserted into a portable electronic device according to one embodiment of
the invention.

[0008]FIG. 4 is a schematic illustration of a breath sensor electrically
embedded into a portable electronic device according to one embodiment of
the invention.

DETAILED DESCRIPTION

[0009]Before any embodiments of the invention are explained in detail, it
is to be understood that the invention is not limited in its application
to the details of construction and the arrangement of components set
forth in the following description or illustrated in the following
drawings. The invention is capable of other embodiments and of being
practiced or of being carried out in various ways. Also, it is to be
understood that the phraseology and terminology used herein is for the
purpose of description and should not be regarded as limiting. The use of
"including," "comprising," or "having" and variations thereof herein is
meant to encompass the items listed thereafter and equivalents thereof as
well as additional items. Unless specified or limited otherwise, the
terms "mounted," "connected," "supported," and "coupled" and variations
thereof are used broadly and encompass both direct and indirect
mountings, connections, supports, and couplings, whether electrical or
mechanical. Further, "connected" and "coupled" are not restricted to
physical or mechanical connections or couplings.

[0010]FIG. 1 illustrates a biosensor system 10 according to one embodiment
of the invention. The biosensor system 10 can include a breath sensor 12,
any necessary hardware 14, and a portable electronic device 16. Some
embodiments of the invention provide a breath sensor 12 in the form of an
electrochemical biosensor that detects one or more analytes in an
individual's breath specific to the human body's metabolic state or
disease state. An example of a metabolic state is fat catabolism and
examples of disease states are hyperthyroidism, ketoacidosis, and
diabetes. In these examples, the breath analyte is acetone. The breath
sensor 12 can generate breath analyte data that can be received by the
portable electronic device 16. The breath sensor 12 can be mechanically
and electrically embedded, or mechanically or electrically integrated,
into the portable electronic device 16.

[0011]The portable electronic device 16 can be capable of receiving the
breath analyte data from the breath sensor 12. The portable electronic
device 16 can also be capable of storing, analyzing, and/or transmitting
the breath analyte data. The portable electronic device 16 can be a
laptop, a cellular phone, a personal digital assistant, a pocket personal
computer, an iPhone®, an iPod®, etc. In some embodiments, the
portable electronic device 16 can transmit and receive the breath analyte
data. In addition, the portable electronic device 16 can be an apparatus
designed specifically for medical uses, such as that disclosed in U.S.
Pat. No. 7,364,551 issued on Apr. 29, 2008, the entire contents of which
is herein incorporated by reference.

[0012]In some embodiments, the breath sensor 12 can be encased in a breath
delivery system 22, as shown in FIGS. 2A-2D and 3. The breath delivery
system 22 can include a mouthpiece (as shown in FIG. 2D) with a first end
through which the individual can blow air so that air passes over the
electrochemical biosensor. The breath delivery system shown and described
in U.S. Provisional Patent Application No. 61/001,172 filed on Oct. 31,
2007, the entire contents of which is herein incorporated by reference,
can be used in some embodiments of the biosensor system 10. Also,
different types of sensors can be placed in the mouthpiece of the breath
delivery system 22. In some embodiments, two different types of sensors
can be placed in the mouthpiece and a switch can alter the air flow from
one sensor chamber to another sensor chamber. For breath acetone
analysis, a detection range can be about 0.1 ppm to about 100 ppm. For
other analytes (e.g., to detect lung diseases or other breath biomarkers
specific to disease states), a detection range can be less than about 0.1
ppm.

[0013]The breath delivery system 22 can include an opening in a second end
of the mouthpiece for making an electrical connection to the portable
electronic device 16. The breath delivery system 22 can be mechanically
inserted into an opening in the housing of the portable electronic device
16. As shown in FIG. 3, the portable electronic device 16 can also
include a suitable display 24.

[0014]In other embodiments, as shown in FIG. 4, the breath sensor 12 can
be embedded into the portable electronic device 16. The portable
electronic device 16 can include the embedded breath sensor 12, the
display 24, and a breath opening 26. Some embodiments of the invention
allow for a single portable electronic device 16 to sense and measure
multiple breath analytes or a combination of breath and blood or other
analytes specific to a metabolic or disease state. Some embodiments of
the invention provide the user a single portable electronic device 16
with multiple analyte detection (versus having multiple stand alone
devices each measuring separate analyte or chemical). Some embodiments of
the invention also allow the user to have a single portable electronic
device 16 which is not restricted to analyte detection, but can be used
with other functionality, such as cellular phone or personal digital
assistant functions. The use of portable electronic devices continues to
increase and more and more features are embedded into the portable
electronic devices. Some embodiments of the invention add a new dimension
or feature to the portable electronic device 16 for use in personal
health and disease management. The breath sensing system 10 can improve
the data collection process by allowing a single portable electronic
device 16 to transmit or receive data to and from the physician and the
individual via wireless or wired connections such as BlueTooth, IR, USB,
etc. The breath sensing system 10 can also improve the time to administer
medical therapies, assess compliance and provide data for insurance
providers, individuals, and physicians.

[0015]In some embodiments, the portable electronic device 16 can include
other embedded health or medical biosensing systems (e.g., a blood
glucose meter), where data signal transmission and receipt may or may not
occur. Some embodiments of the invention integrate a breath acetone
biosensor with a glucose monitor for the tandem detection of breath
acetone and blood glucose. As shown in FIGS. 2A-2D, a lancet 18 and a
blood glucose strip 20 can be used along with the breath delivery system
22 to generate blood glucose data and breath acetone data that can be
stored in the personal electronic device 16 and, in some embodiments,
transmitted from the personal electronic device 16.

[0016]As many current portable glucose monitors measure only blood
products, some embodiments of the invention provide a breath sensor 12
that is compatible for use with a blood glucose monitoring electrical
connector in a portable electronic device 16 for data signal transmission
and receipt (for example, the GlucoPhone cellular phone by HealthPia
America with which blood glucose is monitored). Breath is a gaseous
biomaterial. The breath delivery system 22 can be adaptable to a blood
glucose-type electrode strip (such as disclosed in U.S. Pat. No.
6,609,068 issued Aug. 19, 2003, the entire contents of which is herein
incorporated by reference) that is electrochemically designed to react
with the desired analytes specific to a particular active chemistry. Some
embodiments of the invention integrate a breath acetone biosensor (e.g.,
an enzymatic electrochemical biosensor, e-Nose type biosensors, thermally
resistive biosensors, chemically resistive biosensors, etc.) with other
health and medical sensors for measuring breath, blood, urine, or other
physical or medical attributes, where the integrated device may or may
not be capable of transmitting data.

[0017]The integration of the breath acetone biosensor into a blood glucose
monitor provides the individual with dual functionality in a single
portable electronic device 16 (versus multiple devices). In disease
management, the majority of the type 2 diabetics are overweight and
obese. Using the breath biosensor to monitor diet and fitness in a weight
loss regimen combined with the common need for diabetics to test their
blood sugar (blood glucose measurement) can provide the user with a
single, well-rounded tool to control their health. The data can be sent
to the individual's medical care professional for diagnostic, feedback
and treatment, and medical therapies. The acetone breath sensor can be
integrated with a blood glucose meter that uses blood, or that reads the
eye, or that uses a laser through the finger. The latter two blood
glucose measurements in tandem with breath acetone also provide a fuller
and substantially noninvasive health management system (where data can be
transmitted if desired).

[0018]Some embodiments of the invention include the transmission or
receipt of data via the Internet or other methods specific to
transmitting or receipt of wireless data from the portable electronic
device 16 to a health or medical management system in order to provide
the health/medical professional with information to diagnose, treat and
care for the user (individual) of the biosensor system 10.

[0019]In another embodiment, the ability to sense breath acetone
(electrochemically or by other means) in combination with other analytes
permits the possibility of a dual function portable electronic device 16
that can transmit data. For example, sampling breath acetone and breath
ammonia (NH3) in a single device can allow differentiation between
fat loss and muscle loss, respectively. This dual sensor set can also be
integrated into a respirator mask in a critical care environment.

[0020]Some embodiments of the invention add utility to a portable
electronic device 16 (such as a cellular phone or an iphone) and add
functionality to the common glucose meter with a breath biosensor. Some
embodiments of the invention also add multiple breath tests into a single
portable device, including, for example, an electrochemical breath
acetone test, and integrate portable and potentially data-transmittable
breath acetone measurement with other breath and health measurement
devices. The integration of multiple sensors provides a broader health
picture in a single portable electronic device 16. The biosensor can
detect breath analytes such as acetone, which is a biomarker for fat
metabolism and disease states, such as diabetes and hyperthyroidism.

[0021]Some embodiments of the invention relate to the area of health,
medical and disease management where detection, analysis and
bioinformatics are used. The information from the biosensor can be
transmitted to the individual's physician's database and treatments by
the physician can be suggested remotely. It can also provide for remote
medical care to monitor the efficacy of physician-controlled therapies.
Interface software linked to devices similar to the MedApps system
(www.medapps.net) are optional software/hardware and database-creation
links between physicians and individuals. Also, the physician can create
a database to track the individual or a specific individual population to
develop more effective treatments.

[0022]Some embodiments of the invention can be used by cellular phone
manufacturers, individuals who do not want to carry multiple portable
electronic devices with them (this allows for a multifunctional single
device), physicians who's patients are diabetic (specifically type 2
diabetic to monitor diet compliance), and physicians who perform weight
loss surgeries to help monitor dietary compliance.

[0023]Multiple portable sensors including breath acetone sensing can be
used in emergency rooms and/or respirator masks and/or long term care
hospitals and/or during studies of metabolism and/or during studies of
exercise and/or to monitor long term care patients, such as the elderly,
HIV, cancer patients, and anorexics.

[0024]The following paragraphs describe several embodiments of a breath
sensor 12 integrated with a multifunctional portable electronic device 16
that can, in some embodiments, analyze the data and electronically
receive and transmit the outcome of the analysis of the breath
components.

[0025]In one embodiment, as shown in FIG. 3, the breath sensor 12 is
mechanically inserted through an opening forming an electrical connection
between the breath sensor 12 and the portable electronic device 16.
Breath from the individual activates the breath sensor 12 resulting in an
electrical signal. The electrical signal is transmitted from the breath
sensor 12 to the portable electronic device 16. The portable electronic
device 16 can analyze the signal using a microcontroller or other data
processing component and can then display the outcome on the display 24.
The portable electronic device 16 can store the data and/or the outcome
of the analysis in memory for future access by the individual or medical
professional. The portable electronic device 16 can transmit the data
and/or the outcome of the analysis to a software system used to track the
individual's outcome. The portable electronic device 16 can transmit the
data and/or the outcome of the analysis to a health or medical care
professional for diagnostics, patient records, or medical
therapy/treatment response. The breath sensor 12 can be removed from the
portable electronic device 16 after being used.

[0026]In another embodiment, as shown in FIG. 4, the breath sensor 12 is
mechanically and electrically embedded into the portable electronic
device 16. An opening is designed into the portable electronic device 16
for the breath to be directed to the breath sensor 12. Breath from the
individual can activate the sensor 12 resulting in an electrical signal.
The electrical signal is transmitted from the breath sensor 12 to the
portable electronic device 16. The portable electronic device 16 can
store the data and/or the outcome of the analysis in memory for future
access by the individual or medical professional. The portable electronic
device 16 can transmit the data and/or the outcome of the analysis to a
software system used to track the individual's outcome. The portable
electronic device 16 can transmit the data and/or the outcome of the
analysis to a health or medical care professional for diagnostics,
patient records, or medical therapy/treatment response.

[0027]In another embodiment, the breath sensor 12 is inserted through an
opening and forms an electrical connection between the breath sensor 12
and a multifunctional glucose and breath monitoring device 16. Breath
from the individual can activate the breath sensor 12 resulting in an
electrical signal. The electrical signal is transmitted from the breath
sensor 12 to the monitoring device 16. The monitoring device 16 can store
the data and/or the outcome of the analysis in memory for future access
by the individual or medical professional. The monitoring device 16 can
directly transmit the data and/or the outcome of the analysis to a
software system used to track the individual's outcome. The monitoring
device 16 can directly transmit the data and/or the outcome of the
analysis to a health or medical care professional for diagnostics,
patient records, or medical therapy/treatment response. The breath sensor
12 is removed from the monitor device 16 after being used.

[0028]In another embodiment, the breath sensor 12 is mechanically and
electrically embedded into a dual-detection device such as a glucose
monitoring and breath analyte monitoring device 16. An opening is
designed into the monitoring device 16 for the breath to be directed to
the breath sensor 12. Breath from the individual activates the breath
sensor 12 resulting in an electrical signal. The electrical signal is
transmitted from the breath sensor 12 to the monitoring device 16. The
monitoring device 16 can store the data and/or the outcome of the
analysis in memory for future access by the individual or medical
professional. The monitoring device 16 can directly transmit the data
and/or the outcome of the analysis to a software system used to track the
individual's outcome. The monitoring device 16 can directly transmit the
data and/or the outcome of the analysis to a health or medical care
professional for diagnostics, patient records, or medical
therapy/treatment response.

[0029]The following paragraphs describe examples of a breath acetone
sensing device (e.g., palm-size electrochemical enzymatic sensing device)
integrated with other breath sensing and/or other devices. Therefore,
each of the following examples presents a single device that can provide
a fuller picture of a individual's health status.

EXAMPLE 1

[0030]A breath acetone sensor in tandem with blood glucose meter or pump,
or with a non-invasive blood glucose measuring system, such as eye scan
or infrared (IR) scan through the individual's finger. Integrating both
sensors into a single device provides diabetics much useful information
on their metabolic state in relation to their insulin control.
Integrating the breath acetone sensor with non-invasive methods of blood
glucose measurement can provide both measurements in a fully non-invasive
device. The similarity of the design methods for electrochemical
measurements in a breath acetone and a blood glucose meter make these
devices particularly suitable to integrate. For example, the glucose
electrode strip can be first used in the base unit, then replaced by
inserting a mouthpiece with an electrochemical acetone biosensor using
the same electrical and mechanical connection component as the glucose
strip.

EXAMPLE 2

[0031]A breath acetone sensor in tandem with resting metabolic rate
measurement such as the BodyGem® by Microlife.

EXAMPLE 3

[0032]A breath acetone sensor in tandem with respiratory quotient
measurement or any other metabolic measurement.

[0034]A breath acetone sensor in tandem with any other breath component
sensor [such as alcohol, ammonia (NH3), urea, hydrogen, sulfides,
nitric oxide (NO), isoprene, ethane, pentane, methanol, etc.] or any
other breath condensate measurement. For example, breath acetone and
breath NH3 can provide a combined picture of fat metabolism with
muscle breakdown for energy. This can be helpful for individuals
monitoring their health after bariatric surgery, individuals with
cachexia, or endurance athletes to avoid muscle wasting. NH3 in the
breath can also signal kidney failure, and this plus breath acetone can
provide a more complete health picture. NH3 sensor can be integrated
into a current device using a replaceable NH3 sensor, or by fixing
the sensor and having the breath directed to a different sensor chamber
when the NH3 level is desired. The NH3 sensor can be quartz
microbalance, polymer, chemiresistive, tuning fork, etc. Nitrous oxide
provides information about asthma, and hydrogen regarding digestive
state. Urea is indicative of renal failure. Acetone in tandem with these
items allows a person and/or physician to measure and monitor several
body states in a single device.

[0037]A breath acetone sensor in tandem with heart rate monitor, such as
those manufactured by Polar®, calorimeter or calorie counter, such as
the Bodybugg® by APEX, pedometer, accelerometer, speedometer, VO2
max (which can be defined as the highest rate of oxygen consumption
attainable during maximal or exhaustive exercise), or any other
exercise-related measuring device.

EXAMPLE 9

[0038]A breath acetone sensor in tandem with a scale.

EXAMPLE 10

[0039]A breath acetone sensor in tandem with a fat/water ratio body
measurement such as a body fat monitor, an impedance meter, or other
similar device.

EXAMPLE 11

[0040]A breath acetone sensor integrated into a respirator mask or similar
assisted breathing device. This can provide information to the caregiver
on the metabolic state of the individual. For example, persons with HIV
or cachexia can be monitored for fat bum while they were being ventilated
so that too high an acetone level can trigger adjustments to feeding.

EXAMPLE 12

[0041]A breath acetone sensor in tandem with any of the above examples
where the devices are connected to a computer, phone, or any other data
transmittable device.

[0043]A breath NO sensor connected to a cellular phone can permit
transmission of data regarding airway inflammation, such as occurs with
asthma, to a healthcare provider.

EXAMPLE 15

[0044]A transmittable device such as a cellular phone, walki-talki,
iPod®, or other device with sensors to detect breath analytes or
condensates or airborn contaminants. Data regarding air contamination, or
the state of contaminated individuals, can be transmitted outside the
contaminated area.

[0047]While the system and method have been described in terms of what are
presently considered to be specific embodiments, the disclosure need not
be limited to the disclosed embodiments. It is intended to cover various
modifications and similar arrangements included within the spirit and
scope of the claims, the scope of which should be accorded the broadest
interpretation so as to encompass all such modifications and similar
structures. The present disclosure includes any and all embodiments of
the following claims.